Catalog Number

TMI2000

Brand Name

MIller Advance Catheter

Version/Model Number

5F HS Catheter

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123258,K123258

Product Code

LKF

Product Code Name

Cannula, Manipulator/Injector, Uterine

Public Device Record Key

24d3697c-399f-455e-86b4-272cb8fe44aa

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 10, 2016

Package DI Number

10852073002200

Quantity per Package

10

Contains DI Package

00852073002203

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box